Timeline steps – IVD TRIALS

Do you want to develop an in vitro diagnostic and bring it to market?

To do so, your product must meet certain performance requirements. In Europe, for example, performance is evaluated in accordance with the European In Vitro Diagnostics Regulation 2017/746 (IVDR), which covers three areas: Scientific validity, analytical performance, and clinical performance.

In addition, according to the IVDR, you must evaluate performance both before and after market launch:

What to expect from IVD Trials

As a renowned regulatory expert and contract research organization (CRO), we provide professional support at every step of the performance evaluation process and also offer a variety of studies that are important for evaluation.

For example, with regard to analytical performance under IVDR, we offer testing of all relevant Annex I parameters such as analytical sensitivity, analytical specificity, trueness, precision, and accuracy. Also, in the area of clinical performance, we provide all studies testing Annex I parameters, such as diagnostic sensitivity, diagnostic specificity, positive and negative predictive value, likelihood ratio, and expected values in normal and affected populations.

Also, in the area of clinical performance, we provide all studies testing Annex I parameters, such as diagnostic sensitivity, diagnostic specificity, positive and negative predictive value, likelihood ratio, and expected values in normal and affected populations.

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How we conduct your study – together with you

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Your requirements

Use our easy-to-use standard questionnaire to define your study.

Expert check #1

Our sales team will check the general feasibility of your project. If we do not feel confident, we will neglect your inquiry.

Meeting

In an online meeting – or in person at our German headquarters – we will discuss your project together with you.

Expert check #2

Afterwards, our experts will check the detailed feasibility of your project, the capacity of staff and infrastructure, and the availability of all samples.

Pricing